Biogen reports on Tecfidera multiple sclerosis clinical trials
pharmafile | October 9, 2015 | News story | Research and Development |
Biogen has presented data demonstrating the efficacy and safety of Tecfidera (dimethyl fumarate) across a broad range of people with relapsing-remitting multiple sclerosis (RRMS), at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain.
The data includes important findings for people in the early stages of the disease (as determined by cognitive testing using paced auditory serial addition test three), and coincides with recent recommendations on the importance of early treatment highlighted by the MS Society.
A post-hoc analysis of the Phase III DEFINE and CONFIRM studies showed that dimethyl fumarate had significant effects on clinical outcomes in RRMS patients who initiated treatment early in their disease course, defined as those patients with a baseline Expanded Disability Status Scale (EDSS) score of ≤2.0 (indicating minimal to no disability).
Compared to patients treated with placebo, dimethyl fumarate reduced the adjusted relapse rate (ARR) [95% confidence interval, CI]: 0.132 [0.102, 0.170] vs 0.357 [0.291, 0.438]; 63% reduction; p<.0001) and risk of 12-week confirmed disability progression (0.14 vs 0.24; 40% reduction; p=.0066) over a period of two years.
In an interim analysis of newly-diagnosed patients in the ENDORSE long-term extension study (two years in DEFINE or CONFIRM followed by four years in ENDORSE), the ARR for newly-diagnosed patients (diagnosis of multiple sclerosis within one year prior to study entry or previously treated with cortico-steroids alone) who started dimethyl fumarate treatment at the beginning of the study (n=144) remained low at 0.14 (0.10–0.19).
In those patients who switched from placebo to dimethyl fumarate, the ARR was reduced from 0.26 (0.18–0.37) from the placebo period (years zero to two) to 0.10 (0.06–0.16) when dimethyl fumarate treatment was received (years three to six), representing a 61% reduction of risk; p<0.0001.3
The proportion of patients with 24-week confirmed disability after six years of dimethyl fumarate treatment was 15.7% (95% confidence interval 10.3% – 23.7%), compared to 24.3% (95% confidence interval 15.9% – 36.2%) in those who switched to dimethyl fumarate treatment in year three from placebo, representing a 49% reduction in the risk of confirmed disability progression; p=0.0397.3
“The benefits of taking an efficacious therapy early in the disease course have been shown to improve a patient’s long-term prognosis when treatment is initiated before MS has advanced and caused irreparable damage,” says Ralf Gold, professor and chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum. “The data at ECTRIMS demonstrate that patients initiating treatment with TECFIDERA early in their disease experienced significant reductions in relapse rates and disability progression over time compared to those taking placebo.”
Joel Levy
